Many scientists believe innovations in personalized medicine are poised to yield major breakthroughs in coming years, but not all members of the health care system are clear on which research topics have the most potential. The participants in this panel will identify the most encouraging scientific directions for personalized medicine and point to the most promising topics for future research. Confirmed panelists include:

Innovation requires investment. During this discussion, a panel of diverse investors will illuminate the most promising business opportunities for advancing personalized medicine, focusing on both macro and micro environments while also discussing the barriers to investment and potential solutions for removing them. Confirmed panelists include:

Traditional clinical trial designs are often too cumbersome and expensive to study the efficacy of personalized medicine products and services in sub-populations of patients. Yet there is no consensus on which methods have the most promise to speed trials and lower costs. During this session we will explore which of the latest progressive designs are best suited to demonstrate the efficacy of personalized medicine based on past successes and proposed reforms.

Nowhere are the regulatory and reimbursement challenges facing personalized medicine more evident than in the diagnostics industry, where the routes to market are often hampered by a lack of clarity regarding the possible changes to the regulatory pathway for laboratory-developed tests, ambiguity regarding the kinds of evidence that justify payment, and the need for large marketing budgets to sell low-cost procedures, all of which impede the development of sophisticated diagnostics with the power to transform medicine.

During this panel discussion, representatives from a diverse range of diagnostics companies and a payer will identify the most promising strategies to alter the landscape to encourage the investment in personalized medicine diagnostic products, including the roles of other stakeholders such as the pharmaceutical industry and integrated health systems. Confirmed panelists include:

The fact that payers, providers, patients, industry representatives and regulators all define value differently makes it difficult for personalized medicine’s champions to contribute to and communicate about the body of evidence supporting the field. Participants in this panel discussion will bring the personalized medicine community closer to an accepted definition of value by identifying common elements in multiple stakeholders’ understanding of the concept. Confirmed panelists include:

8:45 a.m. — Coverage is King: Identifying the Evidence That Leads to Reimbursement

Many innovators in personalized medicine are unclear on the kinds of evidence that inform the coverage and payment decisions of payers. That lack of clarity can have negative financial consequences for personalized medicine companies with products and services that are on the market but not paid for. During this panel, payer representatives will help define the reimbursement landscape for the field by providing examples of the evidence they consider appropriate for coverage and payment. Confirmed panelists include:

DNA-editing technologies have been hailed as revolutionary with the possibility to edit out mutations that cause disease. Yet the CRISPR-Cas system is currently locked in a legal dispute between two great research institutions involving, as one journalist put it, “who own molecular biology.” The CRISPR technology in short raises the broader issue of whether these new techniques should be privately owned or placed in the public domain. The technology also raises serious ethical issues. The case study will serve as the point of departure for our discussion of these issues.

Richard Hamermesh, D.B.A., Senior Fellow and Former MBA Class of 1961, Professor of Management Practice, Harvard Business School

Personalized medicine lacks sufficient literature on how health care providers can integrate personalized medicine into clinical care, which makes it difficult for providers to take advantage of the growing number of personalized medicine products and services now available to them. During this session, panelists who have spearheaded integration efforts will share the strategies they found most useful for speeding the pace of personalized medicine’s adoption in clinical settings. Confirmed panelists include:

2:45 p.m. — The Data Dilemma: Defining Information’s Role in the Future of Personalized Medicine

Many innovators believe future advancements in personalized medicine research will be informed by the vast amounts of data that personalized medicine companies and government agencies are now collecting, but the community has not come to a consensus on if, when and how those data can or should be used for research purposes. During this discussion, a panel of academic and industry experts will discuss positions on the circumstances, if any, under which they believe it is appropriate to use these data for research, including issues of data sharing and liquidity. Confirmed panelists include: